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paliperidone ; Carbamazepine

Phase 1

Schizophrenia | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: May 18, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00892125A Study of the Effect of Carbamazepine on the Pharmacokinetics of Paliperidone Extended Release (ER) in Patients With Schizophrenia or Bipolar I DisorderPHASE1 COMPLETED 64Sep 1, 2006Mar 1, 2007May 18, 2011 -
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Study Endpoints
Primary Endpoints
to evaluate the effects of a potent enzyme inducer, carbamazepine, on the steady-state pharmacokinetics of orally administered paliperidone ER
Secondary Endpoints
to evaluate the safety and tolerability of the treatments in clinically stable patients with a diagnosis of schizophrenia or bipolar I disorder
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
paliperidone ER; CarbamazepineDRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosis of schizophrenia of any subtype (295.10 * 295.20 * 295.30 * 295.60 * 295.90) or bipolar I disorder (296.0x, 296.4x, 296.5x, 296.6x or 296.7), according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) * Clinically stable with no p...

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